Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19

Corona Virus Infection Clinical Trial

Official title:

Lung Ultrasound for Assessment of Patients With Moderate to Severe Covid-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04412551
• Other study ID #: LUS-Covid001
• Status: Completed
• Start date: May 20, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2021
• Source: Dalarna County Council, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This observational study will describe lung ultrasound (LUS) findings over time in hospitalized patients with moderate to severe Covid-19 lung disease. Our primary aim is to investigate if lung ultrasound can identify and/or predict patients requiring mechanical ventilation. Another aim is to describe LUS findings associated with clinical findings and patient condition.

Description:

Study patients with moderate to severe Covid-19 infection will be screened with lung ultrasound daily. Lung ultrasound will be assessed by LUS-score for acute respiratory distress syndrome (ARDS) (0-36 points, Bouhemad 2015). Findings of B-line artifacts and consolidations will be noted. In addition to LUS, clinical parameters from physical examination and laboratory tests will be collected. Participants wil be followed until either admission to intensive care unit (ICU) for mechanical ventilation or until clinical improvement. A group of patients with mild Covid-19 infection will be recruited and screened once as reference. Apart from assessment with LUS, patients are managed according to routine care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Covid-19 confirmed by positive polymerase chain reaction (PCR)
• oxygen by mask or nasal prongs = 4 l/min or high flow nasal cannula (HFNC) with fraction of inspired oxygen (FiO2) = 30%
• age between 18-80 years
• informed consent

Exclusion Criteria:

• patients subject to treatment-limitation "no ICU"
• history of heart failure
• history of lung disease e.g.: pneumonectomy, pulmonary fibrosis or other interstitial lung disease, pleurodesis
• history of kidney failure requiring dialysis
• any reason making lung ultrasound or daily follow up impossible
• opposition to participation in the study

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronaviridae Infections
• Coronavirus Infections
• Infection
• Virus Diseases

Locations

Country	Name	City	State
Sweden	Falun Hospital	Falun

Sponsors (1)

Lead Sponsor	Collaborator
Dalarna County Council, Sweden

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Bouhemad B, Mongodi S, Via G, Rouquette I. Ultrasound for "lung monitoring" of ventilated patients. Anesthesiology. 2015 Feb;122(2):437-47. doi: 10.1097/ALN.0000000000000558. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of requirement of mechanical ventilation	Assessment of LUS-score or findings of consolidations correlated to requirement of mechanical ventilation on ICU	3 weeks
Secondary	Prediction of requirement of mechanical ventilation	Assessment if LUS-score or findings of consolidations is able to anticipate clinical deterioration with requirement of mechanical ventilation on ICU	3 weeks
Secondary	Association of LUS to clinical parameters	Descriptive assessment of clinical parameters and LUS-score over time	3 weeks
Secondary	Description of findings on LUS	Description of quality and distribution pattern of LUS-findings in patients with different severities of Covid-19	3 weeks